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FDA Warning Letters: Dairy Farm, Seafood Processor, Dietary Supplement Manufacturers

Mon, 09/01/2014 - 1:03am

The U.S. Food and Drug Administration recently published warning letters issued to a dairy farm, a seafood company and two dietary supplement makers.   

R Style Holsteins of Edison, OH, received a warning letter after selling a cow for slaughter that was considered adulterated because of unacceptable levels of drug residues in its liver.

FDA cited Stock Island Lobster Company of Key West, FL, for “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.”

These violations were failing to list critical points and critical limits in the company’s HACCP plan and failing to follow monitoring procedures for King Mackerel, FDA stated. These include determining the location of harvest for each lot at the time of receipt, determining the adequacy of ice surrounding the product twice daily, and making and keeping an accurate record for the internal temperature of the fish at time of receipt.

Big Easy Confections of Covington, LA, received a warning letter about “serious violations of the Current Good Manufacturing Practice (CGMP) regulations” for dietary supplements. Most of the letter states that the company’s response to the issues from May 27 failed to include supporting documentation for changes made.

The facility also failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, according to the agency. One of the company’s products was also considered misbranded because its label did not identify it with the term “dietary supplement” or include the name and place of business of the manufacturer, packer or distributor.

Another dietary supplement manufacturer, EnerHealth Botanicals of Longmont, CO, faced “serious violations of the Federal Food, Drug, and Cosmetic Act.” FDA determined that five of the company’s products — including “Parasite Purge Herbal Remedy” and “Daily Immune Support” — are “promoted for conditions that cause them to be drugs” and are “not generally recognized as safe and effective for the … referenced uses.”

FDA goes on to state that even if the products did not have therapeutic claims that make them “unapproved new drugs,” they would still be considered adulterated because they were not prepared, packed or held under conditions that meet CGMP regulations.

After inspecting the facility in July 2013, FDA found that EnerHealth, among other things, failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, failed to prepare and follow a written master manufacturing record (MMR), and failed to establish and follow written procedures for packing and labeling, holding and distributing, handling returned dietary supplements, and review and investigation of product complaints. Also, FDA found parts of the responses provided by the company in August and October 2012 to be inadequate.

In the 2014 letter, FDA added that two products are misbranded and that even if the “Daily Immune Support” and “Lung Renewal Herbal Remedy” products were not “unapproved new drugs, they would still be misbranded foods.” All four products failed to have the term “dietary supplement” on their labels. “Lung Renewal Herbal Remedy,” “EchinOsha,” and “Liver Cleanse” also failed to have nutrition labeling. And the “Daily Immune Support” label faced some issues with ingredient declaration, namely that it included botanical ingredients, but not the part of the plant from which each is derived, the agency stated.

In each letter, FDA requested that the farms and companies provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Food Safety Education vs. Reality

Mon, 09/01/2014 - 1:02am

With the new school year fast approaching, it should be a reminder to take the time to properly train and educate food handlers about food safety. Not only just to pass the test and get certified, but to live it, breathe it and foster a culture. Food safety has to be part of the daily routine, not just because the boss is coming for a visit or suddenly the health inspector is at the front door. Fire drills should be avoided. Food safety should be properly managed, not the inspection.

People often forget what they learn in food safety class if it is not applied to a task with any regular frequency and monitored. If they do not understand the consequences of potential illness or are taught in a manner that fosters a “buy in” to the concept, rest assured that most of the information will not be retained. Hands-on training in a working environment are just as important and more successful for some people. Yes, it is a two-way street: the individual must put forth the effort and want to learn.

The reality is that there are language barriers, cultural differences, labor constraints, no sense of urgency and a general feeling of, “That ain’t my job,” when it comes to food safety education.

When I once asked a food handler for their thermometer to check it for calibration and they handed me a roll of sanitizer test strips, that’s a problem. That’s as basic as it comes and reveals how badly the food safety training was neglected. Think about how easily things can spiral out of control with that gross lack of knowledge. Thermal abuse, food contact surfaces, chemical use, and so on and so forth — things can get risky real quick. We cannot just have a warm body processing food anymore since so much more is involved.

Regardless of the excuse, food safety has to be part of the job description and followed up by everyone in the organization. If management puts it on the back burner or not high enough on the priority list, how do they expect the people who actually process the food to feel?

Best practices and increased education should involve everyone.

In the end, the best aspect of teaching food safety should be reality. Putting consumer’s health potentially at risk should always be explained, along with the liability that follows. Sometimes it is the eye-opening truth that inevitably gets the point across.

Labor Day: Don’t Invite Pathogens to Your Picnic

Mon, 09/01/2014 - 1:01am

Thousands of Labor Day picnics and barbecues are being held today in backyards, parks, churches, and at special holiday events all across the country. To make sure that foodborne pathogens aren’t a gatecrasher at your Labor Day celebration, remember to handle picnic foods safety. Here are some helpful tips:

Picnic and barbecue foods (potato salad, hamburgers, hotdogs, watermelon, etc.) are usually handled a lot before they’re consumed. The more they’re handled, the more chances there are for them to become contaminated with foodborne pathogens.

Foods being prepared for a picnic or outdoor gathering are often not cooled rapidly enough, allowing harmful bacteria a chance to grow. Be sure to cool cooked food quickly by putting it in shallow containers and refrigerating it right away.

Since picnic and barbecue food often sits out in warm temperatures for quite a while, keep hot foods hot and cold foods cold to make sure you aren’t encouraging foodborne illness. Bring plenty of ice or frozen gel packs to your picnic or barbecue, along with coolers and insulated containers.

USDA recommends filing insulated containers with boiling water, letting it stand for a few minutes, emptying out the container and then filling it with hot soup, chili or stew. Keep the container closed until it’s time to eat.

Food that needs to be kept cold, especially mayonnaise-based salads and cut melons, should be kept in coolers on ice or surrounded by frozen gel packs. Also, be sure to wash melons before cutting them and immediately refrigerate the pieces. Put foods that need to be chilled in waterproof containers or plastic wrap before placing them in the cooler.

It’s a good idea to put coolers in the passenger area of a car rather than the trunk, where temperatures are usually higher. When you arrive at your picnic site, put the cooler in the shade with a blanket over the top and keep the cooler closed until it’s time to eat.

When grilling food at your picnic or barbecue, wash your hands (or use antimicrobial disposable hand wipes) before touching any food and make sure your cooking tools are clean. Keep cooked food on a lit grill or eat it within an hour of cooking. Put leftovers away as soon as possible and don’t leave cooked food out for more than an hour.

Bring plenty of utensils and dishes so you won’t risk cross-contamination by preparing meat, poultry or fish and then putting them back on the same dishes after they’re cooked. If you must use the same dishes and utensils, be sure to wash them before using them the second time. If there are no washing facilities available, bring disposable plates and utensils.

When cooking meat, be sure it’s thoroughly cooked so juices run clear and there’s no pink in the center. Never partially cook meat and then leave it to sit and finish cooking it later. If you can’t keep hot picnic food hot and the ice has melted in your cooler, throw the food out.

When it comes to food safety, better to be safe than sorry. Happy Labor Day!

Letter From the Editor: Week Five of the PCA Trial

Sun, 08/31/2014 - 1:01am

This past week at the federal criminal trial of three former Peanut Corporation of America (PCA) executives was marked by at least two events.

First, away from the jury, a dispute between the government and former corporate lawyers for PCA was teed up for Judge W. Louis Sands. It is now hanging there for a ruling like a ripe piece of fruit. Second, the former PCA operations manager took the witness stand for several days of testimony. Daniel W. Kilgore is the PCA insider who struck a secret plea deal with the government four days before those on trial were indicted.

Like Samuel Lightsey, the former Blakely, GA, plant manager, Kilgore entered guilty pleas in exchange for consideration at sentencing. And, like Lightsey, his testimony is tedious in its detail. He spent most of six days on the stand, and a wire service reporter covering the trial captured just how laborious testimony from the government’s key witnesses can be.

Much of Lightsey’s time was spent helping prosecutors get one set of documents after another admitted as evidence with questions and answers being repeated like this:

Prosecutor: “Mr. Lightsey, do you recognize these documents?”

Lightsey: “I do.”

Prosecutor: “How do you recognize them?”

Lightsey: “I recognize them from my time at Peanut Corporation of America.”

And then that exchange is repeated for the next set of documents.

Since the government indicted former PCA owner Stewart Parnell, his peanut broker brother Michael, and Mary Wilkerson, the company’s manager of quality control at Blakely, this case has been recognized for its “complexity.” And this goes beyond the microbiological data that’s involved.

The charges of conspiracy, interstate shipments fraud, violations of the federal Food, Drug, and Cosmetics Act, and obstruction of justice require the government to prove that 11 different food industry customers “incurred monetary losses” from doing business with PCA and being on the receiving end of adulterated and misbranded products as a result of fraudulent paperwork that backed up the product.

That’s where Lightsey’s and Kilgore’s testimony have come in. The prosecution has to hope it lays down enough evidentiary detail without putting the jury’s brains to sleep.

What is not clear at this point in the trial is just how badly the prosecution needs statements that the Parnells and Wilkerson might have made to PCA corporate attorneys after the Salmonella outbreak. This was from back when they were dealing with civil litigation from outbreak victims and their families.

Since the defendants “lawyered up” early, the prosecution is looking for statements that might substitute for what the defendants might have said if they were interviewed during the criminal investigation. Are those statements critical to the prosecution or icing on the cake?

Big national law firms involved want the government subpoena for those documents quashed because, they say, handing stuff over to the prosecution would violate attorney-client and work product privileges. For lawyers, those privileges are right up there with the family jewels.

That’s probably why the trial judge asked the government to make another run at arguments against quashing the subpoenas to the corporate law firms and their attorneys. Department of Justice (DOJ) attorney Patrick H. Hearn took on the assignment. He is one of the three prosecutors in the PCA criminal case.

Hearn says that no lawyer-client privilege is involved because none of the three former PCA executives were represented as individuals, just the corporation. He also says it isn’t work product if a lawyer is just collecting facts.

In reading his “supplemental response,” this non-lawyer could not help but think Hearn used the old Star Wars strategy. We all remember this exchange involving Obi-Wan “Ben” Kenobi, don’t we?

BEN: You don’t need to see his identification.

TROOPER: We don’t need to see his identification.

BEN: These are not the droids you’re looking for.

TROOPER: These are not the droids we’re looking for.

BEN: He can go about his business.

TROOPER: You can go about your business.

BEN: (to Luke) Move along.

It will be fascinating to see if the “These are not the droids you’re looking for” argument gets the prosecution what it wants.

Finally, it was great to see this week that victims of the 2008-09 Salmonella Typhimurium outbreak also got some national attention while the trial continues in Albany, GA. Check out this report from Moni Basu of CNN.

Kraft Recalls American Singles for Possible Storage Temperature Problem

Sun, 08/31/2014 - 12:15am

Kraft Foods Group of Northfield, IL, announced Friday that it is voluntarily recalling 7,691 cases of select varieties of regular Kraft American Singles Pasteurized Prepared Cheese Product.

The company stated that a supplier did not store an ingredient used in this product in accordance with Kraft’s temperature standards. While unlikely, this could create conditions that could lead to premature spoilage and/or foodborne illness, so the company issued the recall as a precaution.

Kraft stated that it has had no consumer illness complaints for the product associated with this recall. The affected product is limited to four varieties with “Best When Used By” dates of Feb. 20, 2015, and Feb. 21, 2015.

The affected product was shipped to customers across the United States. It was not distributed outside of the U.S.

The following varieties are being recalled:

ProductSize Name of Product Units/Case Best When Used By Code Dates Package Code Case Code 12 oz. 12 oz Kraft American Singles (16 slices) 48 20 FEB 2015 and 21 FEB 2015 0 21000 60464 7 00 21000 60464 00 16 oz. 16 oz Kraft American Singles (24 slices) (36 count case) 36 20 FEB 2015 0 21000 61526 1 00 21000 61450 00 16 oz. 16 oz Kraft American Singles (24 slices) (12 count case) 12 20 FEB 2015 0 21000 61526 1 00 21000 61526 00 64 oz. 64 oz (4 lb) Kraft American Singles (4×24 slice) 8 20 FEB 2015 0 21000 63360 9 00 21000 62559 00

Consumers can find the “Best When Used By” dates on the bottom of the product package. No other Kraft Singles products are impacted by this recall.

The affected product was produced at Kraft’s Springfield, MO, manufacturing facility.

Consumers who purchased any of these products should not eat them but return them to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-396-5512.

Salmonella Outbreak Linked to Alumni Dinner in Michigan

Sat, 08/30/2014 - 5:28pm

There have been eight laboratory-confirmed cases of Salmonella linked to a Hillsdale County, MI, festival that lasted from July 31 to Aug. 3. There were 33 probable cases.

The outbreak was linked to the Reading Summer Festival Days alumni reunion dinner held on Aug. 2 for all graduates of the city’s schools. Many of the individuals who had been seen by a doctor or were hospitalized were in their 70s, reports the Hillsdale Daily News.

Health officials at the Branch-Hillsdale-St. Joseph Counties Community Health Agency have narrowed the source down to two possibilities, but they are unable to identify it outright.

Every year, Salmonella is estimated to cause 1 million illnesses in the United States, with 19,000 hospitalizations and 380 deaths. Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.

Salmonellosis, the illness caused by the bacteria, usually lasts four to seven days. Although most persons recover without treatment, in some people the diarrhea may be so severe that the patient needs to be hospitalized.

Parmesan Cheese Recalled for Potential Salmonella Contamination

Sat, 08/30/2014 - 1:09pm

4C Foods Corp. of Brooklyn, NY, is recalling 6-oz. glass jars of 4C Grated Cheese HomeStyle Parmesan, UPC 0-41387-32790-8 with code dates BEST BY JUL 21 2016 and JUL 22 2016, due to possible contamination with Salmonella. This recall does not impact any other 4C cheese products.

The potential risk was brought to 4C’s attention by FDA during routine testing. This recall affects 308 cases that were shipped of the affected date codes. No illnesses have been reported to date in connection with this problem.

On July 24, 2014, the product was distributed to: IA, IL, MI, MN, ND, NE, SD and WI through retail stores.

The item is packed as 12 glass jars per case with the code dates BEST BY JUL 21 2016 and JUL 22 2016 located on jar back side toward bottom portion.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.

Consumers do not need to return the product to the store where it was purchased. Instead, consumers are urged to dispose of the recalled product and its container. Please contact 4C Foods at 1-718-272-7800, ext. 176, Monday through Friday, 9:30 a.m. to 4:30 p.m. (EDT), for a replacement or full refund and for general inquiries.

Maine Slaughterhouse Recalls More Than 25,000 Pounds of Beef for Potentially Insufficient Processing

Fri, 08/29/2014 - 10:29pm

Bubier Meats of Greene, ME, has voluntarily recalled 25,192 pounds of beef because the dorsal root ganglia may not have been completely removed. The Maine Department of Agriculture said Friday that state officials had discovered the problem during a review of the company’s slaughter logs.

Federal regulations require removal of the tissue in cattle 30 months of age and older because it can contain bovine spongiform encephalopathy (commonly called “mad cow disease”), which can cause the fatal brain disease in humans who eat tainted beef.

Bubier Meats said carcasses were distributed to Rosemont Market locations in Portland and Yarmouth, ME, and Maine Meat in Kittery, between November 2013 and August 2014.

The products subject to recall include quartered beef carcasses that were stamped with the Maine mark of inspection and establishment number “EST. 4” with the following ship dates: 11/13/13, 11/26/13, 1/2/14, 1/21/14, 2/5/14, 2/19/14, 3/5/14, 3/19/14, 4/2/14, 4/30/14, 5/12/14, 5/28/14, 6/11/14, 6/25/14, 7/9/14, 7/23/14, 8/6/14, 8/20/14.

BSE is a chronic degenerative disease affecting the central nervous system of cattle. It belongs to the group of transmissible spongiform encephalopathies, which include scrapie in sheep and goats and chronic wasting disease of elk and deer.

Consumers with questions about this recall can call Tobie Bubier at (207) 946-5015.

Green Cabbage Likely Caused Minnesota’s Recent E. Coli O111 Outbreak

Fri, 08/29/2014 - 7:07pm

The 15 cases of E. coli O111 reported in Minnesota this summer were probably linked to green whole head cabbage, says the state’s health department.

Health officials’ routine monitoring identified the cases of illness associated with Shiga toxin-producing E. coli O111. Bacterial isolates from all of the cases had the same DNA fingerprint.

The illnesses occurred between June 25 and July 3. Four of the people who became ill were hospitalized, and all have recovered. No new cases connected with this outbreak have been identified in Minnesota since July 10, but there have been single cases of illness matching the outbreak strain in three other states.

Minnesota investigators interviewed 14 of the cases: 13 of them ate at 9 different Applebee’s restaurants in Minnesota, and one ate at Yard House.

Many of those who became ill had reported eating the Oriental Chicken Salad at Applebee’s, leading Applebee’s to voluntarily pull the menu item and specific ingredients from their menu for a time. It was returned to the menu after Applebee’s obtained different sources for the ingredients.

All the victims ate green whole head cabbage, which Minnesota officials traced to a common supplier outside the state and believe was contaminated before it reached the restaurants.

The Minnesota Department of Health and the U.S. Food and Drug Administration are continuing to investigate the source.

Symptoms of illness caused by E. coli O111 typically include stomach cramps and diarrhea, often with bloody stools, but only a low-grade or no fever. People usually become ill two to five days after exposure, but this time period can range from one to at least eight days. Most people recover in five to 10 days. Complications from infection are more common among those with weaker immune systems, including young children and the elderly. As with E. coli O157:H7, infection with E. coli O111 should not be treated with antibiotics, as this practice might promote further complications.

The genetic strain of E. coli O111 from this outbreak had not previously been seen in the U.S.

Government Narrows Scope of Subpoenas for PCA’s Past Corporate Attorneys

Fri, 08/29/2014 - 3:46pm

Government attorneys have filed an additional response to a motion by former attorneys for the Peanut Corporation of America (PCA) to quash a subpoena for information they hold, and here and there they’ve narrowed what they will call good enough.

Department of Justice trial attorney Patrick H. Hearn filed an 11-page memorandum requested by Judge W. Louis Sands within an imposed seven-day deadline. The memo defends the government’s subpoenas of two nationally known law firms, Atlanta-based Weinberg Wheeler Hudgins Gunn & Dial LLC and Meagher & Geer PLLP.

In moving to have those subpoenas quashed, the two law firms raised legal issues involving attorney-client and work product privilege that Sands did not think the government addressed in its first response.

The two law firms are so-called “non-parties” in the current criminal trial underway in Albany, GA, where three former PCA executives have pleaded not guilty to a total of 71 federal felonies. The subpoenaed law firms do not represent any of the three defendants in the criminal trial, but they did represent the now-defunct corporate entity in civil and business matters.

In his “do-over” response, Hearn said the government is seeking “only those documents that reflect any verbatim or near verbatim statements by defendants Stewart Parnell, Michael Parnell, or Mary Wilkerson, concerning their work at PCA.”

Hearn says neither law firm ever represented any of the defendants as individuals. “Both represented the corporate entity PCA,” he writes. “There is, therefore, no attorney-client privilege that attaches to any interactions between and among the defendants and (the two law firms).”

Weinberg Wheeler, which managed the PCA liquidation, signed the joint (criminal) defense agreement, an action that caused the government to limit its subpoena only to materials held prior to Feb. 11, 2009.

Hearn then goes on to argue that the government is not saying that work product protections are waived, but that it questions whether they appropriately apply to the materials requested.

The government memo also says it is seeking only “facts” and that fact-based work product can be subjected to discovery: “Not every document memorializing an oral statement of a witness, in other words, tends to reveal the inner thoughts of an attorney, even if the document is prepared by an attorney.”

Hearn makes it clear that the prosecution team, also including K. Alan Dasher, assistant U.S. Attorney for the Middle District of Georgia and DOJ Consumer Protection Branch trial attorney Mary M. Englehart, is looking for statements the defendants made after the discovery of the 2008-09 Salmonella outbreak.

Previously, the government suggested the court order an in-camera review of the documents held by the two law firms. Now it says it is open to “alternative procedures,” including the appointment of a special master to review privilege logs.

Meanwhile, the trial of the three defendants continued Friday with Daniel W. Kilgore, the former PCA operations manager, on the witness stand for the fourth day. Like former plant manager Samuel Lightsey, Kilgore has a plea agreement with the government, and his testimony as a top PCA insider is likely going to be key to the prosecution’s case.

The trial adjourned on Day 24 for the long Labor Day Weekend. Jurors will return at 8 a.m. on Sept. 2 to hear more testimony until 2 p.m. At 2:30 p.m. that day, Sands has scheduled a “Daubert” hearing for challenges to an unnamed potential expert witness. Jurors will be excused for the day before that hearing begins.

Chinese Citrus Fruit Could be Cleared for U.S. Import: APHIS Invites Comments

Fri, 08/29/2014 - 2:10am

China will have to jump through some hoops, but it may soon be able to sell previously barred citrus fruit in the United States, specifically fresh pomelo, mandarin orange, ponkan (tangerine), sweet orange and Satsuma mandarin fruit.

On Thursday, USDA’s Animal and Plant Health Inspection Service (APHIS) published the proposed rule, which would allow the importation of fresh citrus fruit from China into the continental U.S. The agency invited public comment on the rule for 60 days, ending on Oct. 27, 2014.

Currently, APHIS rules on fruits and vegetables do not permit the import of fresh citrus from China into the U.S. out of concern about certain plant pests. APHIS has received a request from China’s national plant protection organization (NPPO) to allow importation of five citrus fruit species into the U.S.

APHIS proposes to let the Chinese fruit into the U.S. under a condition of entry that includes registration of places of production and packing houses, sourcing of pest-free propagative material, inspection for quarantine pests at set intervals by the NPPO, bagging of fruit, safeguarding post-harvest processing and sampling, and importation in commercial consignment.

Chinese fruit growers would also have to trap for several species of Bactrocera fruit flies, and the fruit would have to be treated for those species of fruit flies. Only fruit that was inspected and found free of pests could be shipped to the U.S.

A pest risk assessment conducted by APHIS identified 22 quarantine pests that could use packed citrus from China as a pathway to the U.S. The NPPO in China will have to provide an operational work plan with detailed procedures, including treatment details.

The importation notice contains no information on the actual distribution of Chinese-grown citrus fruit in the U.S. Comments on the proposed rule are being accepted here.

Members of Congress Want FDA to Drop Agency’s Push for FSMA User Fees

Fri, 08/29/2014 - 2:09am

Representatives Rosa DeLauro (D-CT) and Sam Farr (D-CA) are calling on the White House Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS) to request full funding for implementation of the Food Safety Modernization Act (FSMA) rather than continuing to consider user fees as a funding source.

For the FY 2015 budget, FDA requested $1.48 billion for food safety activities. The $263 million increase over the FY 2014 enacted level included an additional $24 million in budget authority. The request also included $255 million in proposed new user fees, including Food Import and Food Facility Registration and Inspection fees.

In their letter to HHS Secretary Sylvia Mathews Burwell, DeLauro and Farr asked that the Food and Drug Administration “discontinue [the] request for FSMA user fees as they hide the true cost of implementation and will likely be rejected again.”

Congress has rejected the administration’s last five requests for user fees to help implement FSMA, they said.

DeLauro and Farr both serve on House Appropriations Subcommittee for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. During the subcommittee’s hearing in March to discuss the 2015 budget, Rep. Nita Lowey (D-NY) asked FDA Commissioner Margaret Hamburg whether the agency will need more than the proposed $24-million increase requested in discretionary funding.

“To make the kind of progress that we want to make in terms of implementing the Food Safety Modernization Act and the new roles and responsibilities and authorities that Congress gave us … we do need the amount requested in the president’s budget overall,” Hamburg said.

That sentiment echoes FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor’s testimony before the House Energy and Commerce Committee in February: “We will continue efforts to make the best use of the resources we have, but simply put, we cannot achieve FDA’s vision of a modern food safety system and a safer food supply without a significant increase in resources.”

Rather than relying on the user fees that face so much resistance from Congress and industry, DeLauro and Farr want to see “a request for much higher budget authority for FSMA implementation” in the president’s FY 2016 budget.

“In the four years since FSMA was enacted, Congress has provided some of the funding necessary for FSMA implementation, but much more funding will be required to make the larger, up-front investments necessary to ensure the public-health benefits the law promises,” DeLauro and Farr wrote to Burwell and in a second letter to Shaun Donovan, director of the Office of Management and Budget. “Once the major rules are completed in the coming year, FDA will require additional funding to fully implement FSMA.”

When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $580 million to fund the expanded food safety activities. FDA has since revised that estimate to between $400 and $450 million.

The agriculture appropriations bills failed to pass either the House or the Senate this summer. Fiscal Year 2015 begins Oct. 1, so when the House returns from recess in September, it will consider a vote on a short-term continuing resolution that would fund the federal government at current levels until mid-December. After the midterm election on Nov. 4, Congress could vote on a FY 2015 omnibus bill or a second continuing resolution that funds the federal government for the rest of the next fiscal year, or until Sept. 30, 2015.

Food Industry Association Plans to Make GRAS More Transparent

Fri, 08/29/2014 - 2:08am

The Grocery Manufacturers Association (GMA) is taking steps to make food additives more transparent.

The trade organization, representing more than 300 food, beverage and consumer product companies, says their five-part initiative, announced Wednesday, will modernize the process for making “Generally Recognized as Safe” (GRAS) determinations.

The category has been controversial because it allows companies to determine whether a substance is GRAS without having to seek FDA approval. Consumer groups claim that some additives with GRAS status don’t meet the same safety standard as food additives.

The first step in GMA’s plan is to develop a science-based framework that specifies a rigorous and transparent ingredient safety assessment process, which will be documented in a Publicly Available Standard (PAS).

The PAS will be developed by an independent body of technical experts in an open public process that includes interested stakeholders. At the association’s board of directors meeting on Aug. 22, GMA members committed to conducting assessments as defined by the PAS. Nonmembers have not been accounted for.

GMA will also create a database that lists information on all GRAS assessments conducted by the food industry. Information in the database will be made available to FDA and other stakeholders. It is not yet clear what information will be made publicly available.

Lastly, GMA plans to reach out more to stakeholders and consumers on the steps used to assess ingredient safety and will expand its GRAS education curriculum. Earlier this year, the association worked with Michigan State University to create the Center for Research and Ingredient Safety (CRIS).

“Our industry is committed to providing consumers with safe, quality, affordable and innovative products,” said Dr. Leon Bruner, chief science officer for GMA. “We are confident that this initiative, along with the industry’s efforts to implement the Food Safety Modernization Act, will strengthen the food safety programs used by the entire food industry and thereby provide consumers more assurance that food products produced by U.S. manufacturers are, and will remain, the safest available in the world.”

“We are supportive of any initiative that promotes scientific rigor and transparency to independent GRAS determinations, and look forward to further dialogue with GMA and others in an open exchange of information on independent GRAS determinations to ensure the safety of ingredients added to food,” FDA said in a statement. “We encourage industry to voluntarily participate in FDA’s GRAS Notification Program, which FDA makes public through its inventory of GRAS notifications.”

The Center for Food Safety, which filed a lawsuit against FDA in February about its proposed GRAS rule, applauded the GMA’s move toward transparency but is concerned the proposal falls short in addressing some food additive safety concerns. In particular, it applies only to future food additives and does not address the estimated 1,000 self-affirmed GRAS additives already in the food system.

“While industry initiative and cooperation is integral to ensuring the safety of food ingredients, it is not an acceptable substitute for government regulation,” said Donna Solen, CFS senior attorney. “The stakes are simply too high in the area of food safety to allow industry to fill a void left by FDA. For nearly 20 years, FDA has failed to even finalize the regulations that govern GRAS substances, and this is another example of its inaction in this key realm of public health.”

“It is outrageous that FDA doesn’t already have the identity, much less the safety data, of all substances added to the nation’s food supply,” said Laura MacCleery, chief regulatory affairs attorney with the Center for Science in the Public Interest (CSPI). The database that GMA is developing should be completely available to the public, she said.

The effectiveness of GMA’s proposed standard depends on what’s included and how the public is involved in its development, MacCleery told Food Safety News, adding that federal regulation should verify it and require companies to stick to it.

Texas Cyclospora Cases Linked to Mexican Cilantro

Thu, 08/28/2014 - 6:01pm

At least 126 Cyclospora-related illnesses in Texas reported this year have now been traced back to fresh cilantro imported from Mexico, according to the Texas Department of State Health Services.

State and federal health officials revealed the source of the outbreak at the same time they announced that the outbreak was considered over.

The case count spiked in June and July 2014, but any illness occurring after May 1 was considered part of the outbreak. At least 166 Cyclospora cases have been reported in Texas this year.

Of the outbreak cases, 21 were traced back to four restaurants in North Texas that all carried cilantro sourced from Puebla, Mexico. All 21 of those consumed dishes containing the cilantro.

Officials did not find any samples of cilantro contaminated with Cyclospora, but they said there is strong enough epidemiological evidence to link the illnesses to cilantro.

As of August 26, CDC had been notified of 207 ill persons with confirmed Cyclospora infection in 2014 who had no history of international travel within two weeks before onset of illness. The cases have been in Arkansas, California, Connecticut, Florida, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Pennsylvania, New Jersey, New York (and New York City), Texas, Virginia, Wisconsin, and Washington. To date, there is no evidence to suggest that any illnesses outside of Texas are linked to cilantro from Puebla, Mexico.

Last year at this time, 631 people in 25 states — including 270 people in Texas — fell ill in a Cyclospora oubreak also linked to cilantro from Puebla, Mexico, as well as to salad mix from Taylor Farms de Mexico.

Cyclospora is a single-celled parasite that can be found in food or water contaminated by infected feces and often in tropical areas. Symptoms usually appear roughly one week after ingestion and can include watery diarrhea, loss of appetite, stomach cramps and nausea.

Canadian Firm Recalls Smoked Prosciutto for Possible Listeria Contamination

Thu, 08/28/2014 - 5:17pm

The food recall warning for Marc Angelo brand Genoa Salami issued on Aug. 6, 2014, has been updated to include an additional product. The additional product was identified during a Canadian Food Inspection Agency’s (CFIA) food safety investigation.

Concord Premium Meats Ltd. is recalling Marc Angelo brand Smoked Prosciutto Speck, product of Italy, from the marketplace due to possible Listeria monocytogenes contamination. Consumers should not consume the recalled product described below:

Marc Angelo Smoked Prosciutto Speck, 100 g, with a best-before date of 14 NO 02 and UPC 6 27907 05740 3. The product was distributed in Ontario and Quebec.

CFIA recommends that people check to see if they have recalled product in their home. They should be thrown out or returned to the store where purchased.

This recall was triggered by CFIA test results. CFIA is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, CFIA will notify the public through updated Food Recall Warnings. CFIA is verifying that industry is removing recalled product from the marketplace.

There have been no reported illnesses associated with the consumption of this product.

Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still make you sick. Symptoms can include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. Pregnant women, the elderly and people with weakened immune systems are particularly at risk. Although infected pregnant women may experience only mild, flu-like symptoms, the infection can lead to premature delivery, infection of the newborn or even stillbirth. In severe cases of illness, people may die.

PCA’s Former Operations Manager Testifies in Ongoing Criminal Trial

Thu, 08/28/2014 - 1:03am

Daniel W. Kilgore, operations manager for Peanut Corporation of America (PCA) from June 2002 to May 2008 at Blakely, GA, is now testifying in the federal criminal trial in Albany, GA. He is likely to go down as the government’s star witness against the trio of former PCA managers, who today are in the 23rd day of the trial being held in the U.S. District Court for the Middle District of Georgia.

Four days before federal prosecutors dropped a 76-count felony indictment on four other PCA managers, Kilgore stuck a secret deal with the government that saw him plead guilty to 29 counts contained in the indictment in exchange for the promise that his prison time will be limited to 12 years or less.

Kilgore took the witness stand at 9:02 a.m. on Tuesday, undergoing direct examination from Alan Dasher, assistant U.S. Attorney for the Middle District of Georgia. It’s uncertain how long it will be before the three sets of defense attorneys get their opportunity for cross-examination.

It took prosecutors the better part of six days to draw all the direct examination they wanted out of Samuel Lightsey, the former Blakely plant manager, who also reached a plea deal with the government last May.

With Kilgore on the stand, prosecutors have the opportunity to draw out testimony that will confirm Lightsey’s testimony. Kilgore is also able to testify on specific transactions with specific customers. He pleaded guilty to specific instances of mail and wire fraud, and his knowledge of those instances could be critical.

Lightsey’s plea deal caps his potential prison time at six years. In both cases, the sentences are based on guidelines and could be more or less severe. Defense attorneys were quick to point out that Lightsey had every reason to do the most with his testimony to help the government, and they are certain to raise the same point with Kilgore.

Since Lightsey finally ended his testimony a week ago, prosecutors have been calling up a string of witnesses for mostly short bits of testimony. More than a dozen witnesses testified between Lightsey and Kilgore.

Three former executives associated with PCA have pleaded not guilty. They are the ones on trial, including former owner Stewart Parnell, his peanut broker brother, Michael Parnell, and Mary Wilkerson, former quality control manager for the Blakely plant.

The trio is charged with a total of 71 felony counts, including fraud and conspiracy, obstruction of justice and placing misbranded and adulterated peanut butter into interstate commerce. The charges followed a four-year federal investigation into the 2008-09 Salmonella outbreak that sickened more than 700 people and killed nine.

Food Safety Regulations Will Change Industry, Brackett Says

Thu, 08/28/2014 - 1:02am

(This article by Tom Karst, national editor of The Packer, was first published Aug. 26, 2014, and is reposted here with permission.)

The U.S. Food and Drug and Administration’s new food safety regulations aren’t the only changes facing fresh produce marketers, but the coming rules likely will be the most far-reaching, Robert Brackett believes.

In a talk called, “Food Safety Issues on the Horizon: Thinking Differently,” Brackett, a former FDA official and now vice president and director of the Institute for Food Safety and Health at the Illinois Institute of Technology, spoke to attendees of the U.S. Apple Association’s Apple Crop Outlook and Marketing Conference on Aug. 22 in Chicago.

Robert Brackett

Besides new food safety legislation and regulation in the U.S. and other countries, Brackett identified macro changes that include globalization of food trade and production, a rising world population, climate change, diminished land availability, urbanization, global economic shifts and instant communication.

The fallout from these changes will bring increased imports of food, a need for standardized regulations between countries, more biotechnology, higher food prices and increased chances of fraud, he said.

Brackett said economic growth in developing countries will fuel rising consumer expectations and stronger demand for fruits and vegetables, meat and processed foods.

Changes in developed countries, including the U.S., include aging populations, increased reliance on medicine and the emergence of chronic conditions that could lead to health issues such as obesity, heart disease and diabetes, he said. This means a substantial part of the U.S. population is at risk from problems with the safety of the food supply.

“At least 20 percent to 25 percent of the population is at risk and should watch what is in their foods,” he said. At-risk populations include the very young, the very old, those taking medicines and others who may be allergic to food.

Brackett said that 17 percent of the U.S. population is 60 or older, and 4 percent of the population is 80 years old or older. Nearly two-thirds of the population is overweight, and 44 percent of Americans are taking one or more prescription medicines.

New tools online

New epidemiological tools will help identify pathogens, and scientists will be able to trace foodborne illness outbreaks easier, he said.

“We will have tools to allow FDA and (the Centers for Disease Control and Prevention) to find out where outbreaks occur much more accurately and sooner than they have in the past,” he said.

Brackett said researchers will have new molecular testing tools, which will allow better attribution of where problems exist. Next-generation genome sequencing will allow scientists to take a bacterium sample and complete the sequence of the whole genome quickly and cheaply. That type of test used to take as long as a year, but now Brackett says it costs about $100 and several tests can be completed in a day.

The technology will allows scientists, for example, to isolate the place on a packing line where a food safety problem was introduced, he said.

“It is a level of resolution we have never had before on foodborne pathogens,” he said. In the future, handheld equipment for genome sequencing of pathogens may be common, he added.

Another reality of today’s world is consumer engagement in social media, Brackett said.

Whereas the public response to Alar on apples was significant in 1989, a similar event in 2014 would be much more magnified because of social media, he said.

“The response would be in hours, not days or months,” he said.

Misinformation could also be multiplied by false reports on social media, he said.

Brackett also noted the growth of private-label foods by retailers, Brackett said. Those situations will cause suppliers and retailers to look at mutually dependent partnership arrangements, he said. “If there is a foodborne illness issue, you both could go down,” he said.

Private audit standards higher than government standards are also continuing to be imposed on suppliers, he said. The Global Food Safety Initiative aims for a harmonized set of standards across the globe, he said, though acceptance of that standard is not universal.

Food safety systems are under review and change is happening not only in the U.S., but also in China, New Zealand and Canada.

Food safety expectations

With the Food Safety Modernization Act, Brackett said FDA is supposed to have a partnership with the industry.

The new regulations will have a broad prevention mandate and accountability for food suppliers, he said.

“You have to be accountable to FDA inspections that you have prevented something from happening,” he noted.

Imports will have an oversight that is much stricter than in the past.

“Something that was always stated — farm-to-table food safety — it truly is farm-to-table food safety responsibility because we will have FDA investigators on the farm,” Brackett said.

Brackett said “preventive controls” regulations require firms such as fresh-cut apple processors to employ good manufacturing practices.

“I call it HACCP (Hazard Analysis and Critical Control Point) on steroids because these preventive controls are much broader than you have had in the past,” he said.

Eventually, the preventive control regulation may require supplier verification for domestic suppliers, just as FDA will require for import suppliers.

The produce safety rule — applicable to apple growers — will address firms that grow , harvest, pack and hold produce. The regulations will include requirements about water quality, sanitation of equipment, standards for soil amendments and risks posed by specific processes and commodities, he said.

Brackett said the produce safety rule will make it much more difficult for companies which may grow a variety of commodities.

The one part of food safety regulations with the most teeth, Brackett said, is records access for investigators. Certain records must be available to government investigators upon request, he said.

The rules under the Foreign Supplier Verification Program will have a big effect on the industry, he said. The regulation will put the responsibility on importers to confirm that fresh produce imports are grown with the same safety standards as in the U.S.

“The importer of record must prove that to investigators,” he said.

FDA will employ a computer program to help the agency decide which categories of imported food will receive the most scrutiny, he said.

Implications for fresh produce suppliers are several, Brackett said. Companies must develop food safety plans and be able to prove to FDA that procedures are in place to reduce the risk of foodborne illness.

The industry will be asked to get ahead of possible food safety issues, to figure out what could go wrong and prevent it from occurring.

“Ultimately, hopefully there will be safer food and more confidence in the regulatory system and the food industry,” Brackett said.

Brackett said private audit standards will become more important. After he spoke, one apple shipper asked if the number of third-party audits could be reduced through harmonization.

“It’s moving that way, but I think it will be quite some time before we get a harmonized audit system,” Brackett said.

JIFSAN: FDA-University Partnership Helps Enhance the Safety of Imported Food

Thu, 08/28/2014 - 1:01am

A significant portion of the food that Americans consume comes from overseas, and the U.S. Food and Drug Administration (FDA) doesn’t have the ability to inspect all imports, so it’s not a bad idea to intervene with preventive measures before the food reaches our ports.

“It’s much better and more efficient to control the problem at the source,” says Dr. Jianghong Meng, director of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), which is one of FDA’s partners in establishing food safety training programs in other countries.

The collaboration between the agency and the University of Maryland works to train foreign producers and regulators in programs such as Good Agricultural Practices, Good Aquacultural Practices, Commercially Sterile Packaged Foods and inspector training.

JIFSAN was established in 1996 and has “been a very critical component of our international capacity building [efforts],” says Dr. Elizabeth Calvey, director of Collaborative Partnerships at FDA’s Center for Food Safety and Applied Nutrition.

The institute frequently works with countries such as Mexico that supply the U.S. with a lot of produce, major seafood exporters such as Indonesia and Thailand, and spice producer heavyweight India.

In some cases — Malaysia and Jamaica, for example — foreign governments will reach out to JIFSAN directly, seeking help in improving their food safety systems, and they may secure funding for the work through the Food and Agriculture Organization of the United Nations (FAO).

One of the more recent additions to training involves supply chain management for spice production, which began in 2012 after several large-scale Salmonella outbreaks prompted more awareness that spices can be common vehicles for contaminants. In many places, spices are dried outside by the heat of the sun, which can expose them to numerous contaminants, so JIFSAN teaches about how to produce them with less contamination risk.

But it’s not enough just to train individuals. Training the in-country trainers can have much broader success, so that’s where JIFSAN tends to focus their efforts.

Developing countries’ food safety systems “need to take ownership of their own training needs, and they also need to find partners within their countries and develop a plan to establish a sustainable program,” Calvey says. “What we discovered very early on in the 2000s when we started this adventure with JIFSAN was that if you don’t find a partner in a country to take on the responsibility for future training, then the effectiveness of one-off training is not apparent.”

After an initial partnership with JIFSAN in 2009, the Bangladesh Shrimp and Fish Foundation has reached out to many other organizations within Bangladesh, is working with U.S. Agency for International Development, and is developing training programs to enhance their aquaculture industry.

But even when targeting the trainers instead of individual producers, it’s still difficult to measure just how successful the education is at this point, Calvey says.

In addition to international safety training, JIFSAN works in risk analysis, laboratory training and research.

The institute educates food safety and other public health professionals about risk analysis tools and techniques and maintains, which assists professionals involved in conducting food safety risk analyses.

These courses were started just for FDA and Department of Agriculture employees, but today, many participants come from the international community as well. Risk analysis can be tricky to teach in some countries because it requires an established infrastructure that can produce the data central to the approach, but it’s “become a very important component of JIFSAN’s international training programs,” Meng says.

A new initiative launched in 2012 is training for laboratory methods in food microbiology and detection of chemical contaminants. The International Food Safety Training Laboratory (IFSTL) on UM’s campus is open to both domestic and international scientists.

Regarding research, JIFSAN mainly supports collaborations between FDA scientists and UM faculty members. They are currently involved with FDA’s major project in whole-genome sequencing of foodborne pathogens, and the two organizations are working together to develop a training program for the technology and its data analysis.

When there is a research need at the university and FDA doesn’t have the right expertise, JIFSAN will work with other organizations or universities such as Arizona State University and UC Davis to tackle it. It also goes beyond just hands-on laboratory research to include social sciences — for example, studies of how social media influence the spread of outbreak information.

With only 20 people working full-time on JIFSAN, collaboration is definitely important. The majority of instructors are from outside the organization; they’re from FDA, other universities and even industry.

“In our case, without partnership, without collaborations, we can’t do much,” Meng says. “Because food safety itself involves so many different things, it’s a complex problem. It requires solutions that employ all kinds of people and disciplines.”

Chicken Cutlets Recalled for Possible Listeria Contamination

Wed, 08/27/2014 - 4:53pm

TNUVA USA of Fairfield, NJ, is recalling approximately 8,316 pounds of Mom’s Chicken Extra Thin Cutlets due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The product was produced on Aug. 18, 2013, and shipped to the company’s distributor in New Jersey. FSIS will post complete store locations as the list becomes available on its website. The following product is subject to recall:


Bags bear the Israeli establishment number “209” within the Israeli mark of inspection. The product’s expiration date is Feb. 18, 2015, and bears the following UPC number on the packaging: 843426005866.

The problem was discovered when FSIS personnel conducted a routine sampling of product which tested positive for Listeria. FSIS held the product and it did not enter commerce. Further investigation by FSIS determined that other products were produced on the same line without cleanup between products. FSIS and the company are concerned that some product may be frozen and in consumers’ freezers. FSIS and the company have received no reports of illnesses associated with consumption of these products.

Consumption of food contaminated with Listeria can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection can spread beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections can occur in older adults and persons with weakened immune systems.

Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

Update: UK Salmonella Outbreak Linked to Three Deaths Likely Came From a Single Source of Eggs

Wed, 08/27/2014 - 2:05pm

The Salmonella Enteritidis outbreak in the U.K. has now sickened nearly 250 people, and three of them have reportedly died. And, according to public health officials, the illnesses can likely be traced back to a single source of eggs.

Public Health England officials said that 30 cases have now been reported in London, 54 in the West Midlands, 99 in Hampshire and 39 in Cheshire and Merseyside.

The three people who died were at Heartlands Hospital in Birmingham, although officials there said that two of the three deaths were not directly attributed to Salmonella infection.

Thirty-two cases had earlier been linked to The Real China restaurant chain in Eastleigh this past month, officials said. Eastleigh is near Southhampton on England’s southern coast.

Of the total cases, 158 have been reported since Aug. 15, public health staffers said, noting that the case reports had been slowing down. All of the cases were closely related strains of Salmonella Enteritidis, which is often linked to the consumption of poultry or eggs.

While anyone can be infected with Salmonella bacteria, young children, the elderly and people whose immune systems are not working properly have a greater risk of becoming severely ill. Symptoms include watery diarrhea, stomach cramps and sometimes vomiting and fever.